BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEMPLIFI DBM PUTTY

    MDR report key: 7158038 · Received January 2, 2018

    Report

    Report Number
    3000215346-2017-00010
    Event Type
    Injury
    Date Received
    January 2, 2018
    Date of Event
    August 17, 2017
    Report Date
    September 28, 2017
    Manufacturer
    ALLOSOURCE
    Product Code
    MBP
    PMA / PMN Number
    K071849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT FROM THE DISTRIBUTOR, AN INFECTION HAD MATERIALIZED 6 WEEKS POST SURGERY. THE TISSUE BASED MEDICAL DEVICE IS ASEPTICALLY PROCESSED, FREEZE DRIED, AND TERMINALLY STERILIZED VIA ELECTRON BEAM IRRADIATION. 77 TOTAL TISSUE LOTS WERE PRODUCED FROM DONOR (B)(6): 25 DEVICE LOTS, 45 BONE GRAFTS, 7 SOFT TISSUE GRAFTS. 67 TOTAL LOTS WERE DISTRIBUTED: 21 DEVICE LOTS WERE DISTRIBUTED, 4 USED AS QC SAMPLES; 39 BONE LOTS WERE DISTRIBUTED, 6 WERE DISCARDED PRIOR TO DISTRIBUTION; ALL 7 SOFT TISSUE LOTS WERE DISTRIBUTED. ONE LOT OF TISSUE BASED DEVICE WAS IMPLANTED INTO THE PATIENT ASSOCIATED WITH THIS ADVERSE EVENT (B)(4). ALLOSOURCE HAS RECEIVED NO ADDITIONAL REPORTS OF ADVERSE REACTIONS OR ADVERSE EVENTS ASSOCIATED WITH THE OTHER 66 DISTRIBUTED LOTS. 45 TOTAL TISSUE LOTS WERE PRODUCED FROM DONOR (B)(6): 25 DEVICE LOTS, 20 BONE GRAFTS. 41 TOTAL LOTS WERE DISTRIBUTED: 20 DEVICE LOTS, 4 USED AS QC SAMPLES, 1 DISCARDED PRIOR TO DISTRIBUTION; 16 BONE LOTS WERE DISTRIBUTED, AND 4 WERE QUARANTINED. THREE LOTS OF TISSUE BASED DEVICE WERE IMPLANTED INTO THE PATIENT ASSOCIATED WITH THIS ADVERSE EVENT (B)(4). ALLOSOURCE HAS RECEIVED NO ADDITIONAL REPORTS OF ADVERSE REACTIONS OR ADVERSE EVENTS ASSOCIATED WITH THE OTHER 38 DISTRIBUTED LOTS. THIS REPORT WAS NOT SUBMITTED ON THE DATE PREPARED FOR SUBMISSION DUE TO TECHNICAL ISSUES WITH ESG. THESE ARE THE FIRST EMDRS TO BE REPORTED ELECTRONICALLY BY ALLOSOURCE SINCE INITIATION OF THE SYSTEM, AND THE INDIVIDUAL WHO HAD THE ESG ACCOUNT FOR SUBMISSION IS NO LONGER WITH THE COMPANY. ADDITIONALLY, THE ORIGINAL CERTIFICATE REQUIRED TO INITIATE THE WEBTRADER ACCOUNT WITH ESG WAS ON A DEVICE THAT WAS DECOMMISSIONED AND IT COULD NOT REPRODUCE IT. THESE TECHNICAL ISSUES WERE DISCUSSED WITH AN INDIVIDUAL WITH THE EMDR GROUP AT CDRH WHO INFORMED THE REPORTER TO PLACE A NOTE IN SECTION EXPLAINING THE TECHNICAL ISSUES.

    Description of Event or Problem · 1

    FOUR LOTS OF XEMPLIFI DBM PUTTY 10CC, FROM TWO DONORS, MANUFACTURED BY ALLOSOURCE WERE IMPLANTED INTO A PATIENT ON (B)(6) 2017. ON (B)(6) 2017 THE SURGEON NOTIFIED THE PRIVATE LABEL DISTRIBUTOR THAT HE WAS WORRIED THAT THE PATIENT GOT A STAPH INFECTION FROM THE "BONE GRAFT". ALLOSOURCE RECEIVED NOTIFICATION OF THE INCIDENT ON (B)(6) 2017. THE FOUR LOTS OF TISSUE BASED MEDICAL DEVICES REMAIN IN THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SURGEON TO DATE. FOUR SEPARATE ADVERSE EVENT REPORTS ARE BEING SUBMITTED FOR THE EVENT ASSOCIATED WITH THIS PATIENT: 3000215346-2017-00009, 3000215346-2017-00010, 3000215346-2017-00011, 3000215346-2017-00012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375 XEMPLIFI DBM PUTTY BONE VOID FILLLER MBP ALLOSOURCE 8103.0010S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other